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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR/RESERVOIR (LF PORT) OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR/RESERVOIR (LF PORT) OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 1CX*RX25RW
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2021
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted, explanted date: device was not explanted. Occupation- technologist. The actual device has not been returned for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. A review of the device history record and product-release decision control sheet of the involved product code/lot # combination was conducted with no findings. (b)(4).
 
Event Description
The user facility reported that during priming of the capiox device, there was air coming from arterial outlet. There was no delay in the procedure, the product was changed out and the surgery was completed successfully with no patient effect, there was no blood loss.
 
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Brand NameCAPIOX RX25 OXYGENATOR/RESERVOIR (LF PORT)
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
TERUMO CORPORATION, ASHITAKA
150 maimaigi-cho
fujinomiya city, 418
JA 418
Manufacturer (Section G)
TERUMO CORPORATION, ASHITAKA
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, 418
JA 418
Manufacturer Contact
mary o'neill
reg. no. 2243441
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key13060568
MDR Text Key282853479
Report Number9681834-2021-00254
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K040210
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1CX*RX25RW
Device Lot Number210525
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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